NCT02540460

Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371

A Phase I Clinical Study, Multiple Dose of LCB01-0371 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects. To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.

Detailed description

Double blind, randomized, placebo control, multiple dose, dose escalation study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LCB01-0371 800mg	LCB01-0371 800mg
DRUG	LCB01-0371 800mg BID	LCB01-0371 800mg BID
DRUG	LCB01-0371 1200mg BID	LCB01-0371 1200mg BID
DRUG	Placebo	Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2015-09-04
• Last updated: 2015-09-04

Locations

1 site across 1 country: South Korea